The implantation of synthetic tubular prostheses to replace or buttress damaged or diseased vascular vessels or other luminal passageways within the human body is known. Synthetic tubular prostheses include grafts as well as endoprosthetic devices.
Tubular prosthesis such as grafts, are typically implanted by surgical techniques. The surgeon would suture the graft in place in the blood vessel or other body passageway. Other endoprosthetic devices may be implanted intraluminally. These devices may be inserted percutaneously by use of a delivery catheter. Obviously, percutaneous catheter delivery permits implantation of a prosthesis without the need for major surgical intervention and the risks inherent therewith. The art therefore is moving toward the increased use of intraluminal implantation of various prosthetic devices. It has been found that under certain conditions, grafts as well as endoprosthetic devices may be implanted by means of a delivery catheter.
With respect to grafts and other prostheses which may be traditionally surgically implanted, means other than suturing must be found to secure these prostheses in place in the body passageway in order to effectively permit intraluminal implantation. It has been known to employ stents in combination with grafts and various other prostheses to support and secure a prosthesis in place in the body passageway after implantation. Stents are typically radially expandable and/or contractible support members which are positioned inside of the graft or other tubular prosthesis and once the tubular prosthesis is properly positioned, the stent would be expanded to anchor the prosthesis within the body passageway.
However, the use of stents to anchor prostheses is not without problems. Stents sometimes migrate with the flow of body fluid within a vessel if undersized or underexpanded. Also, thrombosis or fibrin buildup may occur within the stent diminishing patency of the intraluminal passageway when the stent is in direct contact with the blood.
U.S. Pat. No. 5,151,105 discloses an implantable, collapsible tubular prosthesis, i.e., graft, for surgical implantation within a vascular organ. The ends of the prosthesis include collapsible circular stents or annular balloons affixed thereto. The stents expand to seal the ends of the endo-vascular prosthesis to the inner luminal surface of the blood vessel into which the prosthesis is implanted. The stents may be sutured to the interior wall such that they are in direct contact with the body fluid therein, or may be placed within annular pockets. Because of the nature of the placement of the stent within the annular pocket, the insertion must take place before implantation. If problems arise surrounding the size of the stent, the tubular prosthesis into which the stent has been sealed must be replaced with a more closely fitting stent.
U.S. Pat. No. 4,728,328 discloses an implantable tubular prosthetic graft having prosthesis cuffs formed on distal ends of the graft. The cuffs are formed by folding the edges of the graft back over itself and bonding the turned back edges to the graft body. These cuffs are then used to suture the graft to the host vessel. Under certain conditions, however, grafts require greater support than that afforded by merely suturing through cuffs positioned at opposing ends of such graft. Also, the need for suturing would preclude catheter delivery.
Accordingly, there is a need for an implantable tubular prosthesis which overcomes the aforementioned shortcomings of the prior art and provides a universal fitting means for cooperatively employing a stent in combination with the tubular prosthesis.